510(k) Report

Devices descending from K894593

536 later devices reach Bonefit Hollow Cylinder Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+4K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+4K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+4K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+4K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+4K162299Spiral Shape Dental Implant SystemGp Implants20173—
+4K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+4K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+4K142167Medentika Abutment SystemMedentika GmbH20157—
+4K140091Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd.20149—
+4K133362SGS Dental ImplantSgs International, Ltd.20142—
+4K140934Hiossen Implant SystemHiossen, Inc.201413—
+4K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+4K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+4K132144KeratorLK Consulting Group USA, Inc.20140—
+4K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+4K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+4K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+4K122171MS SA Implant SystemOsstem Implant Co., Ltd.20122—
+4K122231Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd.201225—
+4K120847ET/SS Implant SystemOsstem Implant Co., Ltd.201275—
+4K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+4K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+4K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+4K103280Bhdental Implant SystemBhdental, Ltd.20110—
+4K101545Genesis Implant SystemKeystone Dental2010153
+4K101096HT Iii SA Fixture SystemHiossen, Inc.2010104—
+4K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+4K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+4K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+4K083550Straumann Dental Implant SystemStraumann USA2009228—
+4K081419Straumann Dental Implant SystemInstitut Straumann AG2009142—
+4K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+4K071803Ards Dental ImplantsArds, Ltd.200813—
+4K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+4K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG20061—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+5K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+5K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+5K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+5K221752StellaShinhung Mst Co., Ltd.20230—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+5K220823Preat AbutmentsPreat Corporation202216
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+5K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+5K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—